Friday, February 1, 2013

Republicans say FDA withholds key meningitis docs

http://www.boston.com/news/local/massachusetts/2013/02/01/republicans-fda-uncooperative-meningitis-probe/8VjXkV6h1LgPJN2M2lOmsJ/story.html



Republicans say FDA withholds key meningitis docs

By MATTHEW PERRONE
AP Health Writer /  February 1, 2013


WASHINGTON (AP) — House Republicans are threatening to subpoena documents from the Food and Drug Administration as part of an ongoing investigation into whether the agency could have prevented a deadly outbreak of meningitis caused by contaminated drugs.

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The FDA inspected the pharmacy three times between 2002 and 2005 and issued a warning letter in 2006 ordering NECC to stop mass-producing drugs outside the scope of its license. But regulators never shut the operation down. At a November hearing, FDA Commissioner Margaret Hamburg said the agency decided to defer the issue to Massachusetts Board of Pharmacy, which had more direct oversight of the company.

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